The purpose of this study is to determine the feasibility of a future trial that will assess whether an integrated intervention combining psychosocial counseling and supported referrals for antiretroviral therapy (ART) at any CD4 cell count and substance use treatment for HIV-infected people who inject drugs (PWID) will reduce HIV transmission to HIV-uninfected injection partners, as compared to routine care dictated by national guidelines for HIV-infected PWID.
This is a multi-site, two-arm, randomized, vanguard study. Network units will consist of an HIV-infected index participant and his/her HIV-uninfected network injection partner(s). Network units will be randomized to the intervention or standard of care arms in a 1:3 ratio, stratified by site. To assess feasibility of the intervention, additional interviews will be conducted with study staff (systems navigators and counselors) and clinic-based stakeholders at each study site. Approximately 500 Index participants and their partners will be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,281
systems navigation, psychosocial counseling
CIPTO
Jakarta, Indonesia
Ukrainian Institute on Public Health Policy
Kiev, Ukraine
Pho Yen Health Center
Hanoi, Vietnam
HIV incidence among network injection partners of index participants
Number of HIV seroconversions to partners to control arm Index participants
Time frame: 18 months
enrollment and retention of HIV-infected PWID and their HIV-uninfected network injection partners
Number of participants enrolled, and number of participants with a final study visit.
Time frame: 18 months
HIV incidence among network injection partners of index participants in the intervention arm
Number of HIV seroconversions to partners of Intervention arm participants
Time frame: 18 months
Engagement in care for ART treatment services of control arm vs intervention
Number of participants in both arms who report being in ART (case report forms) care, as well as testing stored plasma for HIV RNA suppression
Time frame: 18 months
Number of participants in either arm engaged in substance use treatment
self reported on case report forms
Time frame: 18 months
size and stability of drug using networks
self reported data via questionnaire of drug sharing habits and partners at each study visit
Time frame: 18 months
social harms and benefits
self report via questionnaire
Time frame: 18 months
phylogenetics to describe HIV transmission dynamics
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stored plasma samples from those persons who are HIV positive and those who become HIV positive during the study
Time frame: 18 months